First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
184
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Lead sponsor
Amgen
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Start date
2022-08-24
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Number of sites
44
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Summary
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
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Short title
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
clinicaltrials.gov
Official title
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-08-28
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First posted
2022-05-04
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Registry last updated
2026-03-03
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Primary completion date
2028-08-28
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Start date
2022-08-24
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Actual participants
184
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Participants
184
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
44
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05361395
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ClinicalTrials.gov ID
NCT05361395
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with a Dose Limiting Toxicity (DLT)

    Timeframe: 24 months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAE)

    Timeframe: 24 months

  3. Number of Participants with Treatment-related Adverse Events

    Timeframe: 24 months

  4. Number of Participants with Clinically Significant Changes in Vital Signs

    Timeframe: 24 months

  5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements

    Timeframe: 24 months

  6. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Timeframe: 24 months

  1. 6-month Progression-free Survival (PFS)

    Timeframe: 24 months

  2. Objective Response (OR)

    Timeframe: 24 months

    Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  3. Duration of Response (DOR)

    Timeframe: 24 months

  4. Disease Control Rate(DCR)

    Timeframe: 24 months

  5. Overall Survival (OS)

    Timeframe: 24 months

  6. Serum Concentration of Tarlatamab

    Timeframe: 24 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 years old at the same time of signing the informed consent.
  • Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
  • Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
  • Adequate organ function as defined in protocol.

  • History of other malignancy within the past 2 years with exceptions.
  • Major surgery within 28 days of study day 1.
  • Untreated or symptomatic brain metastases and leptomeningeal disease.
  • Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • History of immune-related colitis.
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
  • Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
  • NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
  • History of hypophysitis or pituitary dysfunction.
  • History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Sources for eligibility
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  • University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, United States
  • Christiana Care Health ServicesNewark, United States
  • Henry Ford Health SystemDetroit, United States
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United States
  • New York University Grossman School of Medicine and New York University Langone HospitalsNew York, United States
  • The University of North Carolina at Chapel HillChapel Hill, United States
  • Avera Cancer InstituteSioux Falls, United States
  • Swedish Cancer Institute Medical OncologySeattle, United States
  • West Virginia University Health Sciences CenterMorgantown, United States
  • Chris OBrien LifehouseCamperdown, Australia
  • Universitair Ziekenhuis AntwerpenEdegem, Belgium
  • Algemeen Ziekenhuis Maria MiddelaresGhent, Belgium
  • Jessa Ziekenhuis - Campus Virga JesseHasselt, Belgium
  • AZ Delta Campus RumbekeRoeselare, Belgium
  • Princess Margaret Cancer CentreToronto, Canada
  • CHU de Quebec Hopital de l Enfant JesusQuébec, Canada
  • RigshospitaletCopenhagen, Denmark
  • Centre Leon BerardLyon, France
  • Centre Hospitalier Universitaire de Nantes, Hôpital Nord LaënnecSaint-Herblain, France
  • Gustave RoussyVillejuif, France
  • Universitaetsklinikum DresdenDresden, Germany
  • Universitaetsklinikum EssenEssen, Germany
  • Universitaetsklinikum FreiburgFreiburg im Breisgau, Germany
  • Rambam Medical CenterHaifa, Israel
  • Hadassah Ein-Kerem Medical CenterJerusalem, Israel

And 19 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-511021-58
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (1)

Targets (6)